Official recall record

EsoFLIP Dilation Catheter 30mm

Health Canada — Medical Devices · 2024-05-03 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2024-05-03
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

Medtronic has received complaints of ES-330 catheters measuring diameters that are significantly (more than 50%) lower than actual. The failure mode may be reported as "failed precheck", "incorrect distensibility reading", "no distensibility value displayed", "adverse event without identified device or use problem", or "diameter incorrect." Medtronic Lafayette returned product analysis lab testing of unused, returned ES-330 catheters showed saline conductivity that is approximately 10 times lower than specification. The ES-330 saline conductivity specification is 2.25 mS/cm. The saline conductivity of multiple unused, returned ES-330 catheters had saline conductivity at or near 0.25 mS/cm. Recall start date: April 25, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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